Piramal Imaging announced today that F-18 florbetaben, also known as NeuraCeq, is cleared for commercial marketing by the European Commission.
NeuraCeq is used with PET to image beta-amyloid neuritic plaque density in the living brains of adults with cognitive impairment in order to assess neurodegenerative pathology, especially that of Alzheimer’s disease. While the agent is not defined as an imaging agent for Alzheimer’s disease, it can be used to help rule out the condition.
“With the prevalence of dementia predicted to grow dramatically in the coming decades the global communities are mobilizing to understand the pathology and progression of Alzheimer's disease and other forms of cognitive impairment,” remarked Ludger M. Dinkelborg, PhD, Piramal Imaging director of the board in a release. “The approval of NeuraCeq in Europe will give healthcare providers a new tool to aid in the diagnostic assessment of AD and other causes of cognitive impairment.”
The company is expecting to have the radiopharmaceutical ready for manufacturing and distribution via a partnership with IBA Molecular by the end of third quarter 2014.
A corresponding phase III study involving autopsied patients revealed how PET with NeuraCeq could pattern neuritic beta-amyloid deposition in 31 living brains with 100 percent sensitivity and 86 specificity. A larger cohort of 74 autopsies dropped the percentage of sensitivity slightly to 98 percent and the specificity up to 89 percent.
“Our belief in the diagnostic importance of molecular imaging led us to make a strategic investment in the Bayer research pipeline and create the Piramal Imaging business,” commented Swati Piramal, MD, vice chairperson for Piramal Enterprises. “In just two years we are already at the approval milestone in Europe for the first of our compounds setting us up to provide physicians and patients with valuable information about cognitive impairment and decline. Early diagnosis can be powerful knowledge for certain clinicians and families and may lead to faster action and better care—all of which we value to our core at Piramal Enterprises.”
This is a major success for Piramal, which has been in a holding pattern awaiting a CE mark for this product. IBA Molecular reportedly owns and oversees 49 PET medical isotope production facilities worldwide.